MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the cloth material of the autopulse lifeband was pushed up passed the stitching and was stuck.This was found after the lifeband was retracted down and could not be released.The autopulse platform then displayed a user advisory (ua) 18 (max take-up revolutions exceeded) message.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll (b)(4) on 12/01/2014 for investigation.Investigation results as follows: visual inspection was performed and the reported complaint could not be confirmed; there were no damages observed to the lifeband.The reported information indicated that a user advisory (ua) 18 (max take up revolutions exceeded) displayed on the platform as a result of the customer retracting the lifeband into the ready position prior to it being shipped back to zoll (b)(4) for investigation.The ua 18 is expected to occur when the lifeband is stored in the ready position and is not due to a device deficiency.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4348483
• MDR Text Key: 16448212
• Report Number: 3010617000-2014-00663
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701
• Device Lot Number: 49711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1